Amgen Inc Company Profile
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What is the competitive landscape for AMGEN INC, and when can generic versions of AMGEN INC drugs launch?
AMGEN INC has four approved drugs.
There are fifteen US patents protecting AMGEN INC drugs.
There are two hundred and fifty-nine patent family members on AMGEN INC drugs in fifty-one countries and sixteen supplementary protection certificates in fifteen countries.
Summary for Amgen Inc
International Patents: | 259 |
US Patents: | 15 |
Tradenames: | 3 |
Ingredients: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 9 |
Patent Litigation for Amgen Inc: | See patent lawsuits for Amgen Inc |
PTAB Cases with Amgen Inc as petitioner: | See PTAB cases with Amgen Inc as petitioner |
PTAB Cases with Amgen Inc as patent owner: | See PTAB cases with Amgen Inc as patent owner |
Drugs and US Patents for Amgen Inc
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,867,996*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,650*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | 11,426,404 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,649*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | AB | RX | Yes | Yes | 7,879,842*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for Amgen Inc
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 7,893,101 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 9,018,243 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 7,893,101 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 6,020,358 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 6,020,358 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 9,018,243 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 8,455,536 | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMGEN INC drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
International Patents for Amgen Inc Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2014235273 | ⤷ Try a Trial |
Saudi Arabia | 519410622 | ⤷ Try a Trial |
Brazil | 112015020584 | ⤷ Try a Trial |
Australia | 2020275845 | ⤷ Try a Trial |
Cyprus | 1109010 | ⤷ Try a Trial |
Slovenia | 1485087 | ⤷ Try a Trial |
European Patent Office | 3738593 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amgen Inc Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2962690 | 2019/037 | Ireland | ⤷ Try a Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
2962690 | C201930044 | Spain | ⤷ Try a Trial | PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
2962690 | 1990037-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | C20190029 00295 | Estonia | ⤷ Try a Trial | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
2962690 | LUC00125 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116 |
2962690 | SPC/GB19/045 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116 |
2962690 | C 2019 032 | Romania | ⤷ Try a Trial | PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |